Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools

NCT03940508 | Completed Results DMC

• 1 other identifier: 1R34MH119290-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the "real world" must be addressed. The investigators will examine the effectiveness of the Making Connections Intervention (MCI) and investigate key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products. This study will address an important public health issue: How best to connect Black adolescents with depression to treatment in clinically meaningful ways, and how best to deliver evidence-based treatment to them through school-based services.

Conditions

Depression; Suicidal Ideation

Keywords

depression; treatment engagement; adolescents; Black youth; Intervention

Outcome Measures

Primary Outcomes (15)

• Center for Epidemiological Studies-Depression Scale

  A 20-item self-report scale designed to measure depressive symptomatology in the general population. Scores range from 0 to 60, with higher scores indicating greater depression symptoms. 16 is a common clinical cutoff.

  Baseline

• Hamilton Rating Scale for Depression

  Determines a patient's level of depression before, during, and after treatment. Scores range from 0 to 52, with higher scores indicating greater severity of depression. Scores of 0-7 indicate no depression.

  Baseline

• Demographic Form

  To measure participants' demographic characteristics

  Baseline

• Columbia-Suicide Severity Rating Scale

  To assess the severity and lethality of suicidal behaviors and ideations, and can be used to monitor treatment outcomes and establish suicide risk in a variety of research and clinical settings. "Yes" and "No" categories are used to determine suicide risk, with binary coding where No=0 and Yes=1 for items 1-5. The higher number indicating more intense ideation. Total scores of items 1-5 were analyzed, with the lowest score =0 and the highest score=5.

  Baseline

• Barriers for Adolescents Seeking Health

  Self-report questionnaire that targets barriers to seeking professional psychological help. Scores range from 37 to 111, with higher scores indicating greater barriers to help seeking behaviors.

  Baseline

• Child Help-Seeking Scale

  Self-report 28-item questionnaire designed to measure children's and adolescents' willingness to seek help for psychosocial problems from adults in the school setting. Scores for part one range from 16 to 64 and scores for part two rang from 7 to 28, with higher scores indicating less help- seeking.

  Baseline

• Attitudes Toward Psychological Help Scale

  This scale assesses psychological factors, including stigma, perceived relevance of treatment, etc., that impact one's perceptions of and attitudes about using formal mental health treatment services. Scores range from 0-15, with higher scores indicating greater stigma.

  Baseline

• Stages of Change

  32-item instrument for assessing the readiness for changes in relation to general problems, or problems associated with participation in psychotherapy. The highest score among each sub-scale indicates which stage of change a person is in. Thus, sub-scale scores are reported. Sub-scale scores do not indicate a better or worse outcome; instead, higher scores indicate a readiness to take action to address mental health concerns on each sub-scale. Pre-contemplation scores range from 5-20, Contemplation scores range from 4-16, Action scores range from 5-20, and Maintenance scores range from 4-16.

  Baseline

• Barriers to Treatment Participation Scale

  To test whether perceived barriers to treatment influence dropping out and other measures of participation in treatment. To assess a broad range of barriers evident over the course of treatment, including four thematic areas: stressors and obstacles that compete with treatment, treatment demands and issues, perceived relevance of treatment, and relationship with the therapist. Higher scores indicating greater barriers to treatment. Sub-scale scores range from 20 to 100 (Stressors), 10-50 (Demands), and 8-40 (Perceived Relevance of Treatment).

  Baseline

• Understanding Mood Disorders Questionnaire

  Designed to measure family members' attributions about and knowledge of symptoms, course, and treatment of mood disorders. Scores range from 9 to 40, with higher scores indicating less understanding of how depression presents and functions.

  Baseline

• Therapy Survey

  To measure change in expectations about treatment at a children's psychiatric clinic about a week before their first therapy and counseling sessions. Scores range from 7 to 35, with higher scores indicating misconceptions about the role of therapy.

  Baseline

• Suicidal Ideation Questionnaire-Junior

  A 15-item self-report measure developed specifically for identifying and assessing current suicidal ideation among young adolescents that requires approximately five to eight minutes to complete. Scores range from 0 to 90, with a typical clinical cutoff score of 31 indicating further evaluation due to increased risk of suicidal ideation.

  Baseline

• Global Assessment Scale for Children

  To reflect the lowest level of functioning for a child or adolescent during a specified time period, or on a hypothetical continuum of health-illness. Higher scores indicate higher functioning, ranging from 1-100.

  Baseline

• Interpersonal Needs

  A 15-item questionnaire to measure changes in students' social connectedness and social competence. Total scores ranging from 15-99 are reported with higher scores indicated less social connectedness.

  Baseline

• Penn Helping Alliance Revised

  This questionnaire collects data from both the therapist and patient to measure the strength of the bond between therapist and patient, called the therapeutic alliance. Scores range from 6 to 36, with a higher score indicating greater therapeutic alliance.

  Week 4

Study Arms (2)

MCI + IPT-A

EXPERIMENTAL

Participants will receive the Making Connections Intervention (MCI) in addition to IPT-A for depression.

Behavioral: Making Connections Intervention; Behavioral: IPT-A

IPT-A Only

ACTIVE COMPARATOR

Participants will receive IPT-A for depression.

Behavioral: IPT-A

Interventions

Making Connections Intervention BEHAVIORAL

The MCI is a one to two session intervention that addresses barriers to mental health treatment and helps adolescents build skills to get the most out of their treatment experience. It is designed to be delivered by a trained clinician in conjunction with an evidence-based treatment.

MCI + IPT-A

IPT-A BEHAVIORAL

IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.

Also known as: Interpersonal Psychotherapy for Depressed Adolescents

IPT-A Only; MCI + IPT-A

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Must identify as Black and/or African American
• Must be enrolled in grades 6-12 (except 12th graders in their last semester)
• Must be able to speak English
• Must have received caregiver consent and have assented to participate
• Must meet depression and global functioning levels indicated by a CES-D score ≥16, a Hamilton Rating Scale of Depression (HRSD) Score ≥ 10, and a Global Assessment Scale for Children (C-GAS) score ≤ 65 at baseline

You may not qualify if:

• Actively suicidal with intent or plan
• Intellectually disabled
• Have a life threatening medical illness
• Have a current primary substance abuse diagnosis in the moderate to severe range, schizophrenia, bipolar disorder, any evidence of psychosis, a primary diagnosis of anorexia
• Currently in active treatment for depression (excluding medication) at baseline assessment

Sponsors & Collaborators

• New York University: lead
• National Institute of Mental Health (NIMH): collaborator
• Columbia University: collaborator

Study Sites (2)

Columbia University

New York, New York, 10003, United States

Location

McSilver Institute for Poverty Policy and Research

New York, New York, 10003, United States

Location

Related Publications (10)

• Gunlicks-Stoessel M, Mufson L, Jekal A, Turner JB. The impact of perceived interpersonal functioning on treatment for adolescent depression: IPT-A versus treatment as usual in school-based health clinics. J Consult Clin Psychol. 2010 Apr;78(2):260-7. doi: 10.1037/a0018935.

  PMID: 20350036 BACKGROUND

• Mufson L, Moreau D, Weissman MM, Wickramaratne P, Martin J, Samoilov A. Modification of interpersonal psychotherapy with depressed adolescents (IPT-A): phase I and II studies. J Am Acad Child Adolesc Psychiatry. 1994 Jun;33(5):695-705. doi: 10.1097/00004583-199406000-00011.

  PMID: 8056733 BACKGROUND

• Mufson LH, Dorta KP, Olfson M, Weissman MM, Hoagwood K. Effectiveness research: transporting interpersonal psychotherapy for depressed adolescents (IPT-A) from the lab to school-based health clinics. Clin Child Fam Psychol Rev. 2004 Dec;7(4):251-61. doi: 10.1007/s10567-004-6089-6.

  PMID: 15648279 BACKGROUND

• Lindsey MA, Chambers K, Pohle C, Beall P, Lucksted A. Understanding the Behavioral Determinants of Mental Health Service Use by Urban, Under-Resourced Black Youth: Adolescent and Caregiver Perspectives. J Child Fam Stud. 2013 Jan 1;22(1):107-121. doi: 10.1007/s10826-012-9668-z. Epub 2012 Oct 16.

  PMID: 23355768 BACKGROUND

• Lindsey MA, Joe S, Nebbitt V. Family Matters: The Role of Mental Health Stigma and Social Support on Depressive Symptoms and Subsequent Help Seeking Among African American Boys. J Black Psychol. 2010 Nov 1;36(4):458-482. doi: 10.1177/0095798409355796.

  PMID: 20953336 BACKGROUND

• Breland-Noble AM, Bell CC, Burriss A; AAKOMA Project Adult Advisory Board. "Mama just won't accept this": adult perspectives on engaging depressed African American teens in clinical research and treatment. J Clin Psychol Med Settings. 2011 Sep;18(3):225-34. doi: 10.1007/s10880-011-9235-6.

  PMID: 21512751 BACKGROUND

• Lindsey MA, Korr WS, Broitman M, Bone L, Green A, Leaf PJ. Help-seeking behaviors and depression among African American adolescent boys. Soc Work. 2006 Jan;51(1):49-58. doi: 10.1093/sw/51.1.49.

  PMID: 16512510 BACKGROUND

• Lindsey MA, Brown DR, Cunningham M. Boys do(n't) cry: Addressing the unmet mental health needs of African American boys. Am J Orthopsychiatry. 2017;87(4):377-383. doi: 10.1037/ort0000198.

  PMID: 28691838 BACKGROUND

• Ellis ML, Lindsey MA, Barker ED, Boxmeyer CL, Lochman JE. Predictors of engagement in a school-based family preventive intervention for youth experiencing behavioral difficulties. Prev Sci. 2013 Oct;14(5):457-67. doi: 10.1007/s11121-012-0319-9.

  PMID: 23420474 BACKGROUND

• Lindsey MA, Mufson L, Velez-Grau C, Grogan T, Wilson DM, Reliford AO, Gunlicks-Stoessel M, Jaccard J. Engaging Black youth in depression and suicide prevention treatment within urban schools: study protocol for a randomized controlled pilot. Trials. 2024 Feb 9;25(1):112. doi: 10.1186/s13063-024-07947-8.

  PMID: 38336803 DERIVED

Related Links

• Lu W, Lindsey M, Irsheid S, Nebbitt V. Psychometric properties of the center for epidemiological studies-depression Scale (CES-D) among Black adolescents. Journal of the Society for Social Work and Research. 2017.

MeSH Terms

Conditions

Depression; Suicidal Ideation

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Our recruitment was negatively impacted by COVID-19 and the closure of NYC Schools during the time of the study. While the study team pivoted to virtual recruitment and implementation, our inability to be onsite drastically reduced our ability to build rapport and recruit participants, yielding only 2 participants who completed IPT-A only and 9 who completed MCI+IPT-A. Baseline descriptives are reported only; the small sample size restricted our ability to compare groups on the outcome data.

Results Point of Contact

• Title: Dr. Michael A. Lindsey
• Organization: New York University

michael.lindsey@nyu.edu

212-998-5959

Study Officials

• Michael A Lindsey, PhD

  NYU Silver School of Social Work

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 7, 2019
• Study Start: January 31, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: By the end of data collection, December 2023.
• Access Criteria: In accordance with the NIMH Data Archive requirements.

Locations

US (2)